Devices

Suturing Device

Fabricant

Boston Scientific Corporation
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NZMMDSA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew
  • Modèle / numéro de série
    Product Order #ESD-5:  Lot #1519202, Vendor Exp. 05/2002 * Label Exp. 08/2006, Lot #1520620, Vendor Exp. 05/2002 * Label Exp. 08/2006, Lot #1521208, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1521209, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1521210, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1521211, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1537952, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1540901, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1540902, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1541688, Vendor Exp 06/2003 * Label Exp. 09/2006, Lot #1542196, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1545823, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1546030, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1548352, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1550759, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1551793, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1553535, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1577921, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1577922, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1577923, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1581400, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1582964, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584872, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584573, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584928, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1585415, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1593074, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1595660, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595661, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595662, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595663, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1695664, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1695665, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595666, Vendor Exp. 09/2003 * Label Exp. 03/2007.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Brazil, Canada, Hong Kong, Ireland & Pakistan
  • Description du dispositif
    ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew ¿ Right Device: Flexible TI ¿ Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI ¿ Knot Quickload Units (2) * Disposable ¿ Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
  • Manufacturer
    Wilson-Cook Medical Inc